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Galileo is a Bluetooth insole with embedded pressure sensors that allows monitoring of gait parameters and weight bearing on a smart device application. The primary purpose of this product is to address a lack of tools to treat patients with weight bearing asymmetry (WBA) and is designed to be an affordable tool for use in a clinical setting by physical therapists (PTs) or by patients in their homes. WBA is observed when a person places an uneven amount of weight on their two legs and is a problem that can lead to postural changes, gait instability, an increased risk of injury, and generalized pain. Due to the broad impact of WBA, a method of monitoring this parameter in conjunction with gait mechanics would be beneficial for addressing this issue early and effectively.

Market research revealed that there is currently no affordable solution for PTs and patients to address WBA that provides both reliable, clinically relevant data and real-time feedback on weight bearing for static and dynamic activities. Results of customer discovery surveys illustrated a need in the medical technology market for a low cost and easy to use WBA correction tool for patients and clinicians. Further, the surveys confirmed that the PT market is well disposed to and interested in a device that can provide real-time feedback on WBA and gait parameters for training both in a PT clinic and at home.

Therefore, the team is developing an insole that will communicate via Bluetooth with an application on a smartphone or tablet. The insole will use pressure sensors to gather WBA and gait data in real time, which will be used to generate continuous feedback in the form of auditory cueing during use.  Two auditory cueing options will be available for the patients: 1) Metronome mode, which will provide a tone based on self-selected gait speed and 2) Error detection mode, which will play a tone when a gait or stance error is detected. Additionally, the application will provide a daily report for assessment by a PT or other medical professional. The main priority of this project is to create a design that runs seamlessly for the user and that will provide patients and clinicians with a comfortable, affordable, performance-based solution to address WBA.

To date the team has performed testing on all selected technical hardware components and have confirmed that analog pressure sensor data effectively provides a range of meaningful data. Further, testing has confirmed that this data can be relayed through Bluetooth to a smart device. Through this testing process in combination with feedback from customer validation survey, the team plans to finalize the hardware design by December 9, 2020.

The team has begun the software design phase of the project and have started coding the application. Initial coding will be for the Apple iOS platform with plans to expand to the Android platform in the future.  Prototype building will start once the design is finalized, starting with component procurement. The team has set a target completion date of February 14, 2021 for the first iteration of the prototype. This timeline will allow for up to 4 weeks in delays while accommodating testing of the prototype and acquisition of customer feedback in parallel with demo preparation. It is expected that to build the prototype based on the current design, it will cost a total of $295.56 including subcontracts, equipment, and supplies. Between December 2020-April 2021 it is expected that the team will spend a total of 928 additional person hours on the project to accomplish completion.

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